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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, tracheal, preformed/molded
510(k) Number K182743
Device Name Patient-Specific Airway Stent
Applicant
New Cos Inc.
7100 Euclid Ave, Ste 180
Cleveland,  OH  44103
Applicant Contact Keith Grafmeyer
Correspondent
New Cos Inc.
7100 Euclid Ave, Ste 180
Cleveland,  OH  44103
Correspondent Contact Keith Grafmeyer
Regulation Number878.3720
Classification Product Code
NWA  
Date Received09/28/2018
Decision Date 10/23/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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